Biopharma companies should recognize some of the vernacular they use for negotiating drug development and manufacturing outsourcing can set CDMOs on edge. In this editorial, we talk to biopharma veterans of outsourcing about some of the "financial frictions" brought out in new models for sponsor-provider relationships.
The convergence of data and technologies provides an opportunity for companies to make a step change in innovation and performance. Those that successfully apply the strategies to all parts of the business will thrive in an increasingly complex sector.
Biosimilars were touted as a tool for payers to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step-through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million). So what market access issues do biosimilars face in the U.S., and where could we go from here?
Part one of this series presented neuroscience-based HFE data capture methods that are beginning to penetrate HFE testing programs. This installment will discuss the challenges of utilizing advanced data capture systems in real world HFE testing programs.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
By dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this technology, providing a route to greener, safer chemistry that delivers a higher overall yield.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
By dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this technology, providing a route to greener, safer chemistry that delivers a higher overall yield.
Mention of Turkey in international market discussions can be compared to a game of hide-and-seek: You have to look hard to find it. Unlike the attention-grabbing BRICs (Brazil, Russia, India and China), or the high-flying Asian Tigers (Hong Kong, Singapore, South Korea, and Taiwan), Turkey doesn’t belong to a catchy emerging-market acronym.
A new report, though, forecasts the pharmaceutical market in Turkey to climb to just under $23 billion in 2015. That should help catch and keep the attention of the pharmaceutical and outsourcing industries.
Dry powder inhaler (DPI) devices that utilize two-piece capsules as the dose-holding system can require specialized dosing equipment to fill the capsules. Such products are known as "premetered."
INC Research/inVentiv Health was providing a client with drug safety services for an oncology compound development.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Many biologics companies will partner with a contract development and manufacturing organization that can provide the required expertise and resources as well as flexibility of operations.
In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors. The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process. The result: A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System.
Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.
The $330 bn global sterile market is expected to reach $525 bn by 2020, growing at a CAGR of 11% -with North America contributing 48% while APAC is expected to record highest CAGR of 13%.
